NCT03288532

Renal Adjuvant MultiPle Arm Randomised Trial

An International Investigator-led Phase III Multi Arm Multi Stage Multi-centre Randomised Controlled Platform Trial of Adjuvant Therapy in Patients With Resected Primary Renal Cell Carcinoma (RCC) at High or Intermediate Risk of Relapse

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,750 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: The current global standard of care after nephrectomy for localised RCC therefore remains active monitoring (i.e., observation by clinical and radiological means). 30-40% patients with initially localised RCC develop metastatic disease following nephrectomy. Need for adjuvant therapy is most marked in the high risk population where outcomes are predictably poor. However, the risk of recurrence in patients who are of intermediate risk of recurrence is not insignificant. Unfortunately, despite showing efficacy in advanced RCC, the results in the adjuvant setting, so far, are inconclusive. AIM: RAMPART is a phase III Multi-Arm Multi-Stage randomised controlled platform trial, initiated with three arms. The trial is assessing if durvalumab monotherapy or the combination of durvalumab and tremelimumab can improve Disease Free Survival (DFS) or Overall Survival (OS) compared to the current global standard-of-care (active monitoring). At the start of recruitment, patients with Leibovich scores 3 to 11 will be eligible for randomisation. Accrual of intermediate risk patients (Leibovich scores 3 5) will stop after 3 years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich scores 6 to 11 will continue until the accrual target is reached.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab	controlled infusion via an infusion pump into a peripheral or central vein
DRUG	Tremelimumab	controlled infusion via an infusion pump into a peripheral or central vein

Timeline

• Start date: 2018-07-19
• Primary completion: 2024-07-01
• Completion: 2034-12-01
• First posted: 2017-09-20
• Last updated: 2020-09-07

Locations

35 sites across 1 country: United Kingdom